| CTRI Number |
CTRI/2025/07/090680 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the effect of two Ayurvedic drugs Navakarshika Guggulu and Hardidrakhanda in people exposed to Hives. |
|
Scientific Title of Study
|
Comparative Clinical Study of Navakarshika Guggulu and Haridrakhanda in Sheetpitta (Urticaria) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Udita Kuria |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bharatiya Ayurvigan Evam Anusandhan Sansthan |
| Address |
Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar,Uttarakhand.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
07457814478 |
| Fax |
|
| Email |
udita.kuria97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vikram Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bharatiya Ayurvigan Evam Anusandhan Sansthan |
| Address |
Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar,Uttarakhand.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vdvikram20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vikram Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bharatiya Ayurvigan Evam Anusandhan Sansthan |
| Address |
Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar,Uttarakhand.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vdvikram20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar 249405, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar-249405,Uttarakhand, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Udita Kuria |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar-249405, Uttarakhand, India
Hardwar
UTTARANCHAL |
07457814478
udita.kuria97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navakarshika Guggulu, Reference: Bhavaprakash Madhyakhand, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridrakhanda, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate.
2. Patients with classical symptoms of urticaria.
3. Patients will be selected irrespective of gender and socio economic status. |
|
| ExclusionCriteria |
| Details |
1. Patient having any systemic illness like tuberculosis, carcinoma and endocrine disorders or any major illness like renal or liver disorder.
2. Pregnant and lactating woman.
3. Patients consuming steroids on regular basis for any ailment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters- Grading will be done considering signs and symptoms of sheetpitta-
1. Kotha (Raised skin,lesions,rashes)
2. Kandu (Itching sensation)
3. Toda (Pricking pain)
4. Daha (Burning sensation)
Objective Parameters-
1. No. of wheals
2. Intensityof pruritis
3. Duration of wheals
4. Freq. of appearance
5. Freq. of histamines
is assessed |
0day 30days 60days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective parameters- Grading will be done considering signs and symptoms of sheetpitta-
1. Kotha (Raised skin,lesions,rashes)
2. Kandu (Itching sensation)
3. Toda (Pricking pain)
4. Daha (Burning sensation)
Objective Parameters-
1. No. of wheals
2. Intensityof pruritis
3. Duration of wheals
4. Freq. of appearance
5. Freq. of histamines
is assessed |
0day 30days 60days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label, double arm comparative study, comparing the efficacay of Navakarshika Guggulu 500mg twice daily after meal and Haridrakhanda 4 gm twice daily before meal in 60 patients with sheetpitta(urticaria) that will be conducted in Opd no. 13/14 iin Patanjali Ayurveda Hospital, Haridwar. Assessment will be done on the basis of subjective and objective parameters.
Route of administrarion- Oral route
Follow up- will be done to observe effects of treatment or any adverse effect on the patient.
1st follow up- 1 month after commencement of tratment 2nd follow up- 1 month after the 1st follow. |